VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01426607

Acronym

VASO-AM

Enrollment

150

Registered

2011-08-31

Start date

2011-03-31

Completion date

2015-03-31

Last updated

2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Brief summary

This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.

Interventions

DEVICEAMO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* AHI \> 30 * Intolerance to CPAP therapy * Signed informed consent

Exclusion criteria

* Epworth sleepiness scale \> 16/24 * Severe cardiac and/or respiratory disease * BMI\>32 kg/m2 * Dental contraindication to oral appliance

Design outcomes

Primary

Measure	Time frame
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.	2 months

Secondary

Measure	Time frame
change from baseline to 2-months in markers of OSA severity	2 months
change from baseline to 2-months in blood pressure	2 months
change from baseline to 2-months in symptoms of OSA	2 months
evaluate treatment compliance objectively measured by an embedded micro sensor	15 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026